1. Scrip
  2. >>Therapy Areas
  3. >>Cardiovascular

US safety concerns delay Astellas/Cardiome's Kynapid

 
• By Sue Sutter

A new clinical trial could be required for approval of [C#198600364:Astellas]/[C#199200060:Cardiome] Pharma's novel atrial fibrillation therapy Kynapid (vernakalant HCl injection) in the US, where FDAconcerns about potential cardiovascular adverse events have delayed licensing.

A new clinical trial could be required for approval of Astellas/Cardiome Pharma's novel atrial fibrillation therapy Kynapid (vernakalant HCl injection) in the US, where FDAconcerns about potential cardiovascular adverse events have delayed licensing.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Cardiovascular

Merck & Co. CMO Eliav Barr Assures On Pipeline As Keytruda LOE Looms Large

 
• By Jessica Merrill

Chief medical officer Eliav Barr, responsible for overseeing clinical development, talked to Scrip in an interview at Merck’s headquarters about the company’s pipeline diversification.

CNS, Cardiometabolics A Bright Spot In Recent Chinese VC/PE Fundings

 
• By Dexter Jie Yan

Over the past few months, Chinese developers of CNS and cardiometabolic therapies have attracted the interest of domestic investors, amid generally modest funding activity.

US FDA Expands Label For BMS’s Camzyos Days After Phase III Stumble

 
• By Alaric DeArment

The agency loosened requirements for echocardiograms and removed contraindications for a number of commonly used drugs.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

More from Therapeutic Category

GSK Chief Optimistic About BD Despite Volatile Environment

 
• By Kevin Grogan

Emma Walmsley tells Scrip that the "biotech market is under a certain degree of pressure," so reasonably priced deals are available.

In Brief: AbbVie’s Rinvoq Secures US Approval For Giant Cell Arteritis

 
• By Sushmita Panda

JAK inhibitor gains ninth indication in US after a strong performance in the first quarter.

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By Xu Hu

CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.